Medical break-away connectors

ABSTRACT

Break-away connectors are disclosed. The break-away connectors may be configured to be coupled in at least two configurations, for example, a high force configuration and a low force configuration. The break-away connectors may also be incrementally adjustable between the high force configuration and the low force configuration. The break-away connectors may be coupled to a first medical device and a second medical device. Methods of using and/or coupling the break-away connectors are also disclosed.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/249,713 filed on Nov. 2, 2015 and titled, “Medical Break-AwayConnectors,” and U.S. Provisional Application No. 62/202,377 filed onAug. 7, 2015 and titled, “Medical Break-Away Connectors,” both of whichare hereby incorporated by reference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to medical break-awayconnectors. More specifically, the present disclosure relates tobreak-away connectors configured to be coupled in at least two differentconfigurations and methods of coupling the break-away connectors.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments disclosed herein will become more fully apparent fromthe following description and appended claims, taken in conjunction withthe accompanying drawings. While various aspects of the embodiments arepresented in drawings, the drawings depict only typical embodiments,which will be described with additional specificity and detail throughuse of the accompanying drawings in which:

FIG. 1A is a perspective view of a break-away connector in a coupledstate.

FIG. 1B is an exploded view of the break-away connector of FIG. 1A.

FIG. 1C is an exploded cross-sectional side view of the break-awayconnector of FIG. 1A.

FIG. 1D is a cross-sectional side view of the break-away connector ofFIG. 1A in the coupled state.

FIG. 2A is a perspective view of another embodiment of a break-awayconnector in a coupled state.

FIG. 2B is perspective view of the break-away connector of FIG. 2A in anuncoupled state.

FIG. 2C is a cross-sectional side view of the break-away connector ofFIG. 2A in the uncoupled state.

FIG. 2D is a cross-sectional side view of the break-away connector ofFIG. 2A in the coupled state.

FIG. 3A is a perspective view of another embodiment of a break-awayconnector in a coupled state.

FIG. 3B is an exploded view of the break-away connector of FIG. 3A.

FIG. 3C is an exploded cross-sectional side view of the break-awayconnector of FIG. 3A.

FIG. 3D is a cross-sectional side view of the break-away connector ofFIG. 3A in the coupled state.

FIG. 4A is a perspective view of another embodiment of a break-awayconnector.

FIG. 4B is an exploded view of the break-away connector of FIG. 4A.

FIG. 4C is an exploded cross-sectional side view of the break-awayconnector of FIG. 4A.

FIG. 4D is a cross-sectional side view of the break-away connector ofFIG. 4A in the coupled state.

FIG. 5A is a perspective view of another embodiment of a break-awayconnector in a coupled state.

FIG. 5B is an exploded view of the break-away connector of FIG. 5A.

FIG. 5C is an exploded cross-sectional side view of the break-awayconnector of FIG. 5A.

FIG. 5D is a cross-sectional side view of the break-away connector ofFIG. 5A in the coupled state.

FIG. 6A is a perspective view of another embodiment of a break-awayconnector in a coupled state.

FIG. 6B is an exploded view of the break-away connector of FIG. 6A.

FIG. 6C is an exploded cross-sectional side view of the break-awayconnector of FIG. 6A.

FIG. 6D is a cross-sectional side view of the break-away connector ofFIG. 6A in the coupled state.

DETAILED DESCRIPTION

The various embodiments disclosed herein generally relate to medicalbreak-away connectors. In some embodiments, the break-away connectorscomprise a valve, while in some other embodiments, the break-awayconnectors do not comprise a valve. Break-away connectors may comprise afirst body member and a second body member, wherein the first and secondbody members are configured to be coupled to one another in at least twoconfigurations or settings. Also disclosed herein are methods ofcoupling break-away connectors.

Various features of the connectors disclosed herein may be groupedtogether in a single embodiment, figure, or description thereof for thepurpose of streamlining the disclosure. Many of these features may beused alone and/or in combination with one another in the variousembodiments.

Embodiments may be understood by reference to the drawings, wherein likeparts are designated by like numerals throughout. It will be readilyunderstood that the components of the present disclosure, as generallydescribed and illustrated in the drawings herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description of the embodiments of the apparatusis not intended to limit the scope of the disclosure, but is merelyrepresentative of possible embodiments of the disclosure. In some cases,well-known structures, materials, or operations are not shown ordescribed in detail. While the various aspects of the embodiments arepresented in drawings, the drawings are not necessarily drawn to scaleunless specifically indicated.

The phrases “connected to,” “coupled to,” and “in communication with”refer to any form of interaction between two or more entities, includingbut not limited to mechanical, electrical, magnetic, electromagnetic,fluid, and thermal interaction. Two components may be coupled to eachother even though they are not in direct contact with each other. Forexample, two components may be coupled to each other through anintermediate component.

The terms “proximal” and “distal” refer to opposite ends of a medicaldevice, including the devices disclosed herein. In some instances,break-away connectors may be used as part of a line of medical tubingextending from a patient. As used herein, opposite ends of the breakawayconnectors are defined with reference to use in a line of medical tubingextending from the patient. As such, the proximal end of a break-awayconnector refers to the end oriented away from the patient (along theline of tubing) and the distal end the opposite, or the end closest tothe patient along the line of medical tubing. This coordinate system isutilized regardless of whether the connector is coupled to a patient orline of tubing. Notwithstanding this coordinate system, it is within thescope of this disclosure to reverse the orientation (along a line ofmedical tubing coupled to a patient) of the connectors disclosed herein,in some instances.

The term “resilient” refers to a component, device, or object having aparticular shape that can then be elastically deformed into a differentshape, but that may return to the original shape when unconstrained. Forexample, a resilient arm may extend along the longitudinal direction ofa connector and, in use, the resilient arm may then be constrained(i.e., temporarily engaged with and/or disposed over a ridge portion) toelastically deform it into a second shape (i.e., displaced radiallyoutward due to interaction with the ridge), then unconstrained (i.e.,removed from engagement with the ridge portion) such that the resilientarm returns to its first shape or substantially returns to its firstshape.

The present disclosure generally relates to medical break-awayconnectors. In some embodiments, the break-away connector may comprise afirst body member configured to be coupled to a second body member suchthat fluid communication is provided between each of the first bodymember and the second body member. The first body member may becoupleable to the second body member, or vice versa, in at least twoconfigurations or settings. In various embodiments, a greater force maybe utilized or needed (i.e., as applied or exerted by a practitioner orby a patient) to uncouple the first body member from the second bodymember when the break-away connector is in a first configuration orfirst setting in comparison to when the break-away connector is in asecond configuration or second setting. Furthermore, a transitionbetween the first configuration and the second configuration, and viceversa, may be substantially limited, minimized, or prevented when thefirst body member is coupled to the second body member. A degree orlevel of strength or tightness of the coupling of the first body memberto the second body member may also be continuously or incrementallyadjustable between each of the first configuration and the secondconfiguration, and vice versa.

A fluid seal or valve limiting flow through the body members of abreak-away connector may be associated with one or both of the first andsecond body members. For example, in some embodiments, the first bodymember may comprise a valve such that fluid communication through atleast a portion of the first body member is substantially limited orminimized when the first body member is uncoupled from the second bodymember. Likewise, the second body member may comprise a valve such thatfluid communication through at least a portion of the second body memberis substantially limited or minimized when the second body member isuncoupled from the first body member. In some instances, coupling of thebody members may be configured to open the valve.

In some embodiments, a break-away connector of the present disclosuremay be configured to be placed in fluid communication with a volume of afluid. Additionally, the break-away connector may be configured suchthat the break-away connector may be coupled to one or more of acatheter, an access device, tubing, or another suitable apparatus. Forexample, a proximal end of the break-away connector may be coupled to atube, while a distal end of the break-away connector may be coupled to acatheter, or vice versa. In certain embodiments, the break-awayconnector may be configured to allow or permit the flow or passage of afluid into and/or out of a patient. For example, the break-awayconnector, when coupled to a catheter or tubing, may be used in anintravenous feeding of a patient or in a drainage of a volume of a fluidfrom a patient.

In various embodiments, a catheter may be disposed within a patient atan access site. A proximal end of the catheter that is exterior of thepatient may be coupled to a distal end of a break-away connector.Furthermore, a distal end of a tube that is also exterior to the patientmay be coupled to a proximal end of the break-away connector and aproximal end of the tube may be coupled to a volume of a fluid, such asa collection bag (i.e., for a drainage catheter). In some embodiments,if the patient is ambulatory, the one or more catheters, tubes, and/orbreak-away connector may catch on to or interact with an object such asa chair or a door knob. Such catching or interaction may pull on orotherwise disturb at least a portion of the catheter. Furthermore, suchcatching or interaction may cause or result in damage or injury to theaccess site of the patient. Such catching or interaction may also resultin the catheter being displaced or pulled out of the patient. In someembodiments, a break-away connector as described herein may limit orminimize displacement of the catheter out of a patient and/or limit orminimize injury to the access site of the patient. For example, thebreak-away connector may be configured such that it uncouples (i.e.,into a separate first body member and a separate second body member)when a force above a predetermined level is applied to the break-awayconnector or to one or more devices coupled to the break-away connector.

In various embodiments, the break-away connector may be configured suchthat the break-away connector is relatively easy to uncouple and invarious other embodiments the break-away connector may be configuredsuch that the break-away connector is relatively difficult to uncouple.The selected strength or tightness of the coupling may depend, at leastin part, on the condition or sensitivity of the access site and/or thepatient. The break-away connector may also be configured such thatleakage of a fluid that is flowing or passing through the break-awaycatheter and/or tubing is limited or minimized upon uncoupling of thebreak-away connector. For example, the break-away connector may compriseone or more valves that are configured to inhibit, limit, or minimizefluid flow through the first body member and/or the second body memberof the break-away connector when the break-away connector is in anuncoupled state.

FIG. 1A is a perspective view of a break-away connector 100 in a coupledstate, and FIG. 1B is an exploded view of the break-away connector 100of FIG. 1A. As illustrated, the break-away connector 100 can comprise afirst body member 110 and a second body member 120. In the exploded viewof FIG. 1B, individual components of the first body member 110 are shownin an unassembled state. The uncoupled state of the break-away connector100 corresponds to a configuration wherein the components of the firstbody member 110 are assembled together, but the first body member 110and the second body member 120 are not coupled. The components of thefirst body member 110 may be assembled and coupled during manufacture,while the first body member 110 and the second body member 120 may beselectively coupleable by a user.

Again, in some embodiments, the first body member 110 can be coupled tothe second body member 120, and vice versa, by a user. With reference toFIG. 1B, the first body member 110 may comprise a first portion 111, asecond portion 112, and a valve 113. The valve 113 may be disposedwithin the first body member 110 (i.e., between each of the firstportion 111 and the second portion 112). The first portion 111 and thesecond portion 112 may be coupled to each other by at least one of acompression fit, a snap fit, an adhesive, or another suitable couplingmechanism. In some embodiments, the first body member may comprise onlya single portion or another suitable number of portions.

The first body member 110 can further comprise a coupling end portion114 and a break-away end portion 115. As depicted, the coupling endportion 114 may be disposed at an end of the first body member 110opposite from the break-away end portion 115. The coupling end portion114, as illustrated, comprises a male connector. As discussed in furtherdetail below, however, the coupling end portion 114 may comprise anysuitable coupling mechanism. The first body member 110 may furthercomprise one or more resilient arms. For example, the first body member110 may comprise a first resilient arm 116 a and a second resilient arm116 b, wherein the resilient arms 116 a, 116 b extend longitudinallyaway from the coupling end portion 114 of the first body member 110.Furthermore, the one or more resilient arms 116 a, 116 b may compriseone or more ridge portions or raised portions. For example, the firstresilient arm 116 a may comprise a first ridge portion 117 a extendinginwardly toward a longitudinal axis of the break-away connector 100, andthe second resilient arm 116 b may comprise a second ridge portion 117 bextending inwardly toward the longitudinal axis of the break-awayconnector 100. One or more slots may be disposed adjacent, between, orwithin the one or more resilient arms 116 a, 116 b. For example, asillustrated, a first slot 118 a and a second slot 118 b can be disposedbetween each of the first resilient arm 116 a and the second resilientarm 116 b. In some embodiments, the break-away connector 100 maycomprise one, two, three, four, five, or more resilient arms, ridgeportions, and/or slots.

Likewise, the second body member 120 can also comprise a coupling endportion 124 and a break-away end portion 125, wherein the coupling endportion 124 may be disposed at an end of the second body member 120opposite from the break-away end portion 125. The coupling end portion124, as illustrated, comprises a female connector. Again, as discussedin further detail below, the coupling end portion 124 may also compriseany suitable coupling mechanism. The break-away end portion 125 of thesecond body member 120 can comprise one or more ridge portions or raisedportions. For example, the break-away end portion 125 can comprise afirst ridge portion 127 a and a second ridge portion 127 b (see FIG.1C). One or more ribs may also be disposed adjacent or between the oneor more ridge portions 127 a, 127 b. For example, the break-away endportion 125 may comprise a first rib 128 a and a second rib, wherein thesecond rib is disposed on a portion of the second body member 120 thatis opposite of the portion of the break-away end portion 125 comprisingthe first rib 128 a. In certain embodiments, the one or more ribs 128 amay be configured to be at least partially disposed within at least aportion of the one or more slots 118 a, 118 b upon coupling of the firstand second body members 110, 120.

In various embodiments, the one or more ridge portions 117 a, 117 b ofthe first body member 110 may be configured to engage or interact withthe one or more ridge portions 127 a, 127 b of the second body member120. Additionally, the first and second body members 110, 120 may becoupleable in at least two configurations or settings. In someembodiments, a greater force may be required to uncouple the first bodymember 110 from the second body member 120 when the break-away connector100 is in a first configuration or a first setting in comparison to whenthe break-away connector 100 is in a second configuration or a secondsetting. For example, a practitioner uncoupling the first body member110 from the second body member 120 may apply, exert, or utilize agreater amount of force (i.e., mechanical force) to uncouple the firstbody member 110 from the second body member 120 when the break-awayconnector 100 is in the first configuration than when the break-awayconnector 100 is in the second configuration. In some other embodiments,the first and second body members 110, 120 may be coupleable in three,four, five, or more configurations, wherein each configuration maycomprise a different level of strength or tightness.

In some embodiments, an amount of force needed to uncouple the firstbody member 110 from the second body member 120 may be less than anamount of force needed to dislodge a suture, or to remove a catheterfrom a patient. For example, the amount of force needed to uncouple thefirst body member 110 from the second body member 120, and vice versa,may be less than at least 10 pounds, less than at least 5 pounds, lessthan at least 4 pounds, less than at least 2 pounds, etc. In variousembodiments, the amount of force needed to uncouple the first bodymember 110 from the second body member 120 may be between about 0.5pounds and about 10 pounds, between about 0.5 pounds and about 8 pounds,between about 0.5 pounds and about 6 pounds, between about 0.5 poundsand about 5 pounds, between about 0.5 pounds and about 4 pounds, betweenabout 0.5 pounds and about 2 pounds, and so on. In some embodiments, theamount of force needed to uncouple the first body member 110 from thesecond body member 120 may be between about 0.5 pounds and about 10pounds, between about 2 pounds and about 10 pounds, between about 4pounds and about 10 pounds, between about 5 pounds and about 10 pounds,between about 8 pounds and about 10 pounds, between about 9.5 pounds andabout 10 pounds, and so on. In certain embodiments, the amount of forceneeded to uncouple the first body member 110 from the second body member120 may be between about 0.5 pounds and about 10 pounds, between about 2pounds and about 4 pounds, between about 2 pounds and about 8 pounds,between about 4 pounds and about 8 pounds, between about 6 pounds andabout 8 pounds, between about 4 pounds and about 6 pounds, and so on.Such amounts of force needed to uncouple a first body member from asecond body member of a break-away connector may analogously and/orequally apply to all embodiments of the break-away connector asdescribed herein (e.g., break-away connectors 100, 200, 300, 400, 500,600).

FIG. 1C is an exploded cross-sectional side view of the break-awayconnector 100 of FIG. 1A. As depicted, the first body member 110 cancomprise two resilient arms 116 a, 116 b. Additionally, the slot 118 acan be at least partially disposed between each of the two resilientarms 116 a, 116 b. As discussed above, the second body member 120 cancomprise one or more ribs 128 a (see FIGS. 1A and 1B). In certainembodiments, at least a portion of the one or more ribs 128 a can beconfigured to be disposed within at least a portion of the one or moreslots 118 a, 118 b when the first body member 110 is coupled to thesecond body member 120, such that rotation of the first body member 110in relation to the second body member 120 around a longitudinal axis ofthe break-away connector 100 may be substantially limited or minimized.Stated another way, the engagement or interaction of the first bodymember 110 with the second body member 120, via the slots, resilientarms, and ribs, may substantially limit or minimize displacement orrotation of the first body member 110 and the second body member 120between each of the first configuration and the second configuration,and vice versa. Still further, interaction of the one or more ribs 128 a(see FIGS. 1A and 1B) and a portion of the one or more slots 118 a, 118b may facilitate alignment of the first body member 110 and the secondbody member 120 when coupled.

In some other embodiments, the first body member 110 may comprise onlyone resilient arm, wherein the one resilient arm may comprise a singleslot. Furthermore, the second body member 120 may comprise only one rib,wherein at least a portion of the rib is configured to be disposedwithin at least a portion of the slot when the first and second bodymembers 110, 120 are coupled to each other, such that rotation of thefirst body member 110 in relation to the second body member 120 aroundthe longitudinal axis of the break-away connector 100 is substantiallylimited or minimized. As discussed above, engagement or interaction ofthe rib with the slot may substantially limit or minimize rotation ofthe first body member 110 in relation to the second body member 120, orvice versa.

As shown in FIG. 1C, the first body member 110 can further comprise afirst lumen 105 disposed within at least a portion of the first bodymember 110, wherein the first lumen 105 is configured to provide fluidcommunication between a first end and a second end of the first bodymember 110. The second body member 120 can also further comprise asecond lumen 106 disposed within at least a portion of the second bodymember 120, wherein the second lumen 106 is configured to provide fluidcommunication between a first end and a second end of the second bodymember 120. Furthermore, when the first and second body members 110, 120are coupled to one another, the first lumen 105 may be configured to bein fluid communication with the second lumen 106 (i.e., the first lumen105 may be substantially aligned with the second lumen 106).

The break-away connector 100, as illustrated, may further comprise aseal member 132, wherein the seal member 132 is configured tosubstantially limit or minimize fluid communication between each of thefirst lumen 105 and/or the second lumen 106 with an exterior environmentof the break-away connector 100 when the first and second body members110, 120 are coupled to one another. For example, the seal member 132may be configured to limit or minimize leakage of a fluid from withinthe break-away connector 100 to the exterior environment of thebreak-away connector 100. In certain embodiments, the seal member 132may be an O-ring or another suitable sealing mechanism.

FIG. 1D is a cross-sectional side view of the break-away connector 100of FIG. 1A in the coupled state. With reference to each of FIGS. 1C and1D, the first body member 110 can comprise the first resilient arm 116 aand the second resilient arm 116 b. As illustrated, the height orprofile of the first ridge portion 117 a of the first resilient arm 116a can be greater than the height or profile of the second ridge portion117 b of the second resilient arm 116 b. Likewise, the second bodymember 120 can comprise the first ridge portion 127 a and the secondridge portion 127 b, wherein the height or profile of the first ridgeportion 127 a can be greater than the height or profile of the secondridge portion 127 b. As described above, the break-away connector 100may comprise one, two, three, four, five, or more resilient arms, eachresilient arm comprising a ridge portion. Additionally, the break-awayconnector 100 may comprise one, two, three, four, five, or more ridgeportions of the second body member 120. Each of the plurality of ridgeportions 117, 127 of the first body member 110 and/or the second bodymember 120, respectively, may have different heights or profiles and/ora combination of heights or profiles such that the break-away connector100 may comprise a variety of coupling strengths or tightnesses.Accordingly, in certain embodiments, the break-away connector 100 maycomprise one, two, three, four, five, or more coupling strength ortightness configurations.

In some embodiments, the first configuration may be a high forceconfiguration. In the first configuration or the high forceconfiguration, the first ridge portion 117 a of the first resilient arm116 a may engage or interact with the first ridge portion 127 a of thesecond body member 120 (the configuration shown in FIG. 1D). In such aconfiguration, two high profile ridge portions (e.g., the first ridgeportions 117 a, 127 a) may engage or interact with each other. Incertain embodiments, the second configuration may be a low forceconfiguration. In the second configuration or the low forceconfiguration, the first ridge portion 117 a of the first resilient arm116 a may engage or interact with the second ridge portion 127 b of thesecond body member 120. In such a configuration, a high profile ridgeportion (e.g., the first ridge portion 117 a) may engage or interactwith a low profile ridge portion (e.g., the second ridge portion 127 b).In certain embodiments, uncoupling of a break-away connector 100 whentwo high profile ridge portions are engaged with each other may utilizeor require a greater force than uncoupling of the break-away connector100 when a high profile ridge portion is engaged with a low profileridge portion.

With reference again to FIGS. 1A and 1B, the first resilient arm 116 acan comprise a first indicium 130 a (e.g., an “H” for high or anothersuitable indicium), and a portion of the second body member 120 adjacentthe first ridge portion 127 a can comprise a second indicium 130 b(e.g., an arrowhead or another suitable indicium). When the firstindicium 130 a and the second indicium 130 b are substantially aligned(i.e., upon coupling of the first and second body members 110, 120) thebreak-away connector 100 can be in the high force configuration.Conversely, when the first indicium 130 a is substantially aligned witha portion of the second body member 120 opposite of the second indicium130 b the break-away connector 100 can be in the low forceconfiguration. Again, interaction of the one or more ribs 128 a and aportion of the one or more slots 118 a, 118 b may facilitate alignmentof the first body member 110 and the second body member 120 when coupledand when selecting between the high force configuration and the lowforce configuration.

Referring again to FIG. 1D, the valve 113 can be disposed within atleast a portion of the first lumen 105. In some embodiments, the valve113 may be disposed within at least a portion of the second lumen 106.In some other embodiments, a first valve may be disposed within thefirst lumen 105 and a second valve may be disposed within the secondlumen 106.

As illustrated, the break-away connector 100 may comprise a first valveengagement member 134 disposed within the first lumen 105 and/or coupledto the first body member 110. The break-away connector 100 may alsocomprise a second valve engagement member 135 disposed within the secondlumen 106 and/or coupled to the second body member 120. As illustrated,the first valve engagement member 134 comprises a post-like memberconfigured to engage a center portion of a first surface of the valve113. In some other embodiments, the first valve engagement member 134may be substantially conical, substantially semispherical, or anothersuitable shape. In contrast, the second valve engagement member 135, asillustrated, comprises a raised, substantially annular surfaceconfigured to engage a portion of a second, or opposite, surface of thevalve 113 disposed radially in relation to the center portion of thevalve 113. In some embodiments, the second valve engagement member 135may be substantially square, substantially triangular, or anothersuitable shape. The engagement or interaction of the first and secondvalve engagement members 134, 135 with the valve 113 may be configuredto open the valve 113 when the first and second body members 110, 120are coupled to one another. For example, the first and second valveengagement members 134, 135 may be displaced toward each other. Thefirst valve engagement member 134 may be configured to displace thecentral portion of the valve 113 toward the second valve engagementmember 135, and the second valve engagement member 135 may be configuredto displace the portion of the valve radially disposed relative to thecentral portion of the valve 113 toward the first valve engagementmember 134. Such displacement of the above-described portions of thevalve 113 may result in the transition of the valve 113 from the closedconfiguration to the open configuration.

Other mechanisms of opening the valve 113 are also within the scope ofthis disclosure. For example, the break-away connector 100 may includeonly one valve engagement member (i.e., similar to the first valveengagement member 134). Engagement or interaction of the one such valveengagement member with the valve 113 may result in the transition of thevalve 113 from the closed configuration to the open configuration. Incertain embodiments, the valve 113 may be formed from a resilientmaterial (e.g., a polymeric material or another suitable material) suchthat the valve 113 is also configured to transition from the openconfiguration to the closed configuration upon disengagement of the oneor more valve engagement members 134, 135 from the valve 113. Withreference to FIG. 1D, the valve 113 can further comprise an aperture136, wherein the aperture 136 may be configured to transition from aclosed configuration to an open configuration upon engagement betweenthe one or more valve engagement members 134, 135 and the valve 113.Furthermore, the aperture 136 may also be configured to transition fromthe open configuration to the closed configuration upon disengagement ofthe one or more valve engagement members 134, 135 from the valve 113.

In various embodiments, the coupling end portion 114 of the first bodymember 110 may be configured to be coupled to a first medical device,and the coupling end portion 124 of the second body member 120 may beconfigured to be coupled to a second medical device. For example, asdiscussed above, the break-away connector 100 may be configured for usein medical procedures including, but not limited to, drainage of avolume of a fluid from a patient and intravenous feeding of a patient.The break-away connector 100 may be configured to be coupled to a fluidcontainer such as an IV bag. The break-away connector 100 may also beconfigured to be coupled to a catheter, wherein at least a portion ofthe catheter is disposed in a patient at an access site. The break-awayconnector 100 may be configured to function or operate as a flowregulator in combination with an IV assembly. In some embodiments, thebreak-away connector 100 may be configured to adjust a rate of flow orpassage of a fluid through the break-away connector 100. For example,the break-away connector 100 may further comprise a twist controlmechanism or a needle valve.

In certain embodiments, each of the coupling end portions 114, 124 maycomprise a different type of coupling mechanism. For example, thecoupling end portion 114 may comprise a female connector and thecoupling end portion 124 may comprise a male connector. In anotherexample, the coupling end portion 114 may comprise a threaded couplingmechanism (e.g., a female connector or a male connector) and thecoupling end portion 124 may comprise a compression fitting, a snapfitting, or another type of suitable fitting. In various otherembodiments, each of the coupling end portions 114, 124 may comprise thesame type of coupling mechanism. For example, each of the coupling endportions 114, 124 may comprise a female connector. In another example,each of the coupling end portions 114, 124 may comprise a maleconnector. In yet another example, each of the coupling end portions114, 124 may comprise a compression fitting, a snap fitting, or anothertype of suitable fitting.

In some embodiments, the first body member 110 may be removablycoupleable to the second body member 120 via a tether (not shown). Forexample, during packaging, shipment, and/or storage of the break-awayconnector 100 the first and second body members 110, 120 of thebreak-away connector 100 may be coupled to one another via a tether suchthat the first and second body members 110, 120 may not be separatedand/or lost during packaging, shipment, and/or storage.

In another embodiment, the break-away connector 100 may comprise apre-lock mechanism. For example, the second body member 120 may compriseone or more ridge portions or an annular ridge portion (not shown) thatis configured to engage the ridge portions 117 a, 117 b of the one ormore resilient arms 116 a, 116 b of the first body member 110. In someembodiments, a pre-lock ridge portion may be disposed such that thevalve 113 is not disposed in an open configuration upon coupling of thefirst and second body members 110, 120 from or to the pre-lockconfiguration. Accordingly, the application or exertion of mechanicalstress on the valve 113 may be limited or minimized during packaging,shipping, and/or storage.

The pre-lock ridge portion of the second body member 120 may have alower height or profile than either of the ridge portions 127 a, 127 b,such that the resilient arms 116 a, 116 b are radially biased orextended outward from the longitudinal axis of the break-away connector100 to a lesser degree or extent than when the ridge portions 117 a, 117b of the resilient arms 116 a, 116 b are engaged with the ridge portions127 a, 127 b of the second body member 120. Such a configuration maylimit or minimize the mechanical stress applied to or exerted on theresilient arms 116 a, 116 b during packaging, shipment, and/or storageof the break-away connector 100 in a coupled state. For example, thepre-lock ridge portion may be configured such that the first and secondbody members 110, 120 may be coupled to one another while the resilientarms 116 a, 116 b may be only minimally or slightly biased or extendedradially outward from the longitudinal axis of the break-away connector100 during engagement into the pre-lock configuration.

FIGS. 2A-2D illustrate another embodiment of a break-away connector thatcan, in certain respects, resemble components of the break-awayconnector described in connection with FIGS. 1A-1D. It will beappreciated that all the illustrated embodiments may have analogousfeatures. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “2.” For instance, thefirst body member is designated as “110” in FIGS. 1A-1D, and ananalogous first body member is designated as “210” in FIGS. 2A-2D.Relevant disclosure set forth above regarding similarly identifiedfeatures thus may not be repeated hereafter. Moreover, specific featuresof the break-away connector and related components shown in FIGS. 1A-1Dmay not be shown or identified by a reference numeral in the drawings orspecifically discussed in the written description that follows. However,such features may clearly be the same, or substantially the same, asfeatures depicted in other embodiments and/or described with respect tosuch embodiments. Accordingly, the relevant descriptions of suchfeatures apply equally to the features of the break-away connector ofFIGS. 2A-2D. Any suitable combination of the features, and variations ofthe same, described with respect to the break-away connector andcomponents illustrated in FIGS. 1A-1D can be employed with thebreak-away connector and components of FIGS. 2A-2D, and vice versa. Thispattern of disclosure applies equally to further embodiments depicted insubsequent figures and described hereafter.

FIG. 2A is a perspective view of a break-away connector 200 in a coupledstate, and FIG. 2B is a perspective view of the break-away connector 200of FIG. 2A in an uncoupled state. As illustrated, the break-awayconnector 200 can comprise a first body member 210 and a second bodymember 220. Analogous to the break-away connector 100 (see FIGS. 1A-1D),the first body member 210 can be coupled to the second body member 220,and vice versa. In contrast to the break-away connector 100, however,the break-away connector 200 as illustrated in FIG. 2B does not comprisea valve. In some embodiments, however, the break-away connector 200 maycomprise one or more valves. For example, a first valve may be disposedwithin at least a portion of the first body member 210 and a secondvalve may be disposed within at least a portion of the second bodymember 220.

The first body member 210 can further comprise a coupling end portion214 and a break-away end portion 215. The coupling end portion 214, asillustrated, comprises a female connector. As stated above, however,other suitable coupling mechanisms are also within the scope of thisdisclosure. The first body member 210 may further comprise one or moreresilient arms, analogous to the resilient arms 116 a, 116 b. Forexample, the first body member 210 may comprise a first resilient arm216 a and a second resilient arm 216 b. Furthermore, the one or moreresilient arms 216 a, 216 b may comprise one or more ridge portions orraised portions. For example, the first resilient arm 216 a can comprisea first ridge portion 217 a and the second resilient arm 216 b cancomprise a second ridge portion 217 b. Additionally, one or more slots(e.g., a first slot 218 a and a second slot 218 b) may be disposedadjacent, between, or within the one or more resilient arms 216 a, 216b.

The second body member 220 can also comprise a coupling end portion 224and a break-away end portion 225. As depicted, the coupling end portion224 comprises a male connector. Again, as stated above, other suitablecoupling mechanisms are also within the scope of this disclosure. Thebreak-away end portion 225 of the second body member 220 can compriseone or more ridge portions or raised portions. For example, thebreak-away end portion 225 of the second body member 220 comprises afirst ridge portion 227 a and a second ridge portion 227 b (see FIG.2C). Furthermore, one or more ribs (e.g., a first rib 228 a and a secondrib disposed on an opposite side of the second body member 220 from thefirst rib 228 a) may be disposed adjacent or between the one or moreridge portions 227 a, 227 b. In certain embodiments, the one or moreribs 228 a may be configured to be at least partially disposed within atleast a portion of the one or more slots 218 a, 218 b upon coupling ofthe first body member 210 and the second body member 220.

In various embodiments, the one or more ridge portions 217 a, 217 b ofthe first body member 210 may be configured to engage or interact withthe one or more ridge portions 227 a, 227 b of the second body member220 (i.e., upon coupling of the first and second body members 210, 220).Additionally, upon coupling of the first body member 210 with the secondbody member 220, the first and second body members 210, 220 may becoupleable in one of at least two configurations, as described above inreference to break-away connector 100. In some embodiments, a greaterforce may be utilized or required to uncouple the first and second bodymembers 210, 220 when the break-away connector 200 is in a firstconfiguration or a first setting in comparison to when the break-awayconnector 200 is in a second configuration or a second setting. Forexample, a practitioner uncoupling the first and second body members210, 220 may apply, exert, or utilize a greater amount of force (i.e.,mechanical force) to uncouple the first and second body members 210, 220when the break-away connector 200 is in the first configuration incomparison to when the break-away connector 200 is in the secondconfiguration.

FIG. 2C is a cross-sectional side view of the break-away connector 200of FIG. 2A in an uncoupled state. As depicted, the first body member 210comprises the first resilient arm 216 a and the second resilient arm 216b. As stated above, in some other embodiments, the first body member 210may comprise one, two, three, four, five, or more resilient arms. Thefirst slot 218 a can be at least partially disposed between each of thefirst and second resilient arms 216 a, 216 b. As discussed above, thesecond body member 220 can comprise one or more ribs 228 a (see FIG.2A). In some embodiments, at least a portion of at least one of the ribs228 a can be configured to be disposed within at least a portion of eachof the first and second slots 218 a, 218 b upon coupling of the firstand second body members 210, 220. The disposition of at least a portionof the rib 228 a within at least a portion of the slot 218 a may beconfigured to substantially limit or minimize rotation of the first bodymember 210 in relation to the second body member 220 around alongitudinal axis of the break-away connector 200 when the first andsecond body members 210, 220 are coupled to one another. As statedabove, the engagement or interaction of the first and second bodymembers 210, 220 may substantially decrease or inhibit displacement orrotation of the first and second body members 210, 220 between each ofthe first configuration and the second configuration, and vice versa.This interaction may also facilitate alignment of the first body portion210 and the second body portion 220 during coupling.

FIG. 2D is a cross-sectional side view of the break-away connector 200of FIG. 2A in the coupled state. With reference to each of FIGS. 2C and2D, the first body member 210 can comprise a first resilient arm 216 aand a second resilient arm 216 b. As illustrated, the height or profileof the first ridge portion 217 a of the first resilient arm 216 a can begreater than the height or profile of the second ridge portion 217 b ofthe second resilient arm 216 b. Likewise, the second body member 220 cancomprise a first ridge portion 227 a and a second ridge portion 227 b,wherein the height or profile of the first ridge portion 227 a can begreater than the height or profile of the second ridge portion 227 b. Asdescribed above, the break-away connector 200 may comprise one, two,three, four, five, or more resilient arms, each resilient arm comprisinga ridge portion. Additionally, the break-away connector 200 may compriseone, two, three, four, five, or more ridge portions of the second bodymember 220. Each of the plurality of ridge portions 217, 227 of thefirst body member 210 and/or the second body member 220, respectively,may have different heights or profiles and/or a combination of heightsor profiles such that the break-away connector 200 may comprise avariety of coupling strengths or tightnesses. Accordingly, in certainembodiments, the break-away connector 200 may comprise one, two, three,four, five, or more coupling strength or tightness configurations.

As discussed above, the first configuration may be a high forceconfiguration. In the first configuration or the high forceconfiguration, the first ridge portion 217 a of the first resilient arm216 a may engage or interact with the first ridge portion 227 a of thesecond body member 220. In such a configuration, two high profile ridgeportions (e.g., the first ridge portions 217 a, 227 a) may engage orinteract with each other. In certain embodiments, the secondconfiguration may be a low force configuration. In the secondconfiguration or the low force configuration, as illustrated in FIG. 2D,the first ridge portion 217 a of the first resilient arm 216 a mayengage or interact with the second ridge portion 227 b of the secondbody member 220. In such a configuration, a high profile ridge portion(e.g., the first ridge portion 217 a) may engage or interact with a lowprofile ridge portion (e.g., the second ridge portion 227 b). In certainembodiments, uncoupling of a break-away connector 200 when a highprofile ridge portion is engaged with a low profile ridge portion mayutilize or require less force than uncoupling of the break-awayconnector 200 when two high profile ridge portions are engaged with oneanother.

With reference again to FIGS. 2A and 2B, the second resilient arm 216 bcan comprise a third indicium 230 c (e.g., an “L” for low or anothersuitable indicium), while a portion of the second body member 220adjacent the first ridge portion 227 a can comprise a second indicium230 b (e.g., an arrowhead or another suitable indicium). When the secondindicium 230 b and the third indicium 230 c are substantially aligned(i.e., upon coupling of the first and second body members 210, 220) thebreak-away connector 200 can be in the low force configuration, incontrast to the high force configuration depicted in FIGS. 1A and 1D.Each of the embodiments of FIGS. 1A-1D and FIGS. 2A-2D can be disposedin either a high force configuration or a low force configuration. Insome embodiments, a different combination of indicia may be utilized toindicate different coupling configurations or settings of the break-awayconnector. For example, in embodiments comprising three or moreresilient arms and/or ridge portions of the second body member,additional coupling configurations may be possible, wherein eachconfiguration may comprise a different degree or level of couplingstrength or tightness.

In certain embodiments, the first body member 210 may be formed from afirst material and the second body member 220 may be formed from asecond material. For example, the first body member 210 may be formedfrom a XENOY polymer blend and the second body member 220 may be formedfrom a material other than a XENOY polymer blend. A XENOY polymer blendmay be partially or substantially resistant to cracking or deforming.For example, a body member formed from a XENOY polymer blend may be moredurable (i.e., upon being cleaned or sterilized) than a body memberformed from another material. Further, forming each of the first andsecond body members 210, 220 from different materials (i.e., a firstmaterial and a second material) may limit or minimize galling or bindingbetween each of the first and second body members 210, 220. Othersuitable materials and combinations of materials are also within thescope of this disclosure.

FIG. 3A is a perspective view of a break-away connector 300 in a coupledstate, and FIG. 3B is an exploded view of the break-away connector 300of FIG. 3A. As illustrated, the break-away connector 300 can comprise afirst body member 310 and a second body member 320. Analogous to thebreak-away connectors 100, 200, the first and second body members 310,320 of the break-away connector 300 are coupleable. Also, the uncoupledstate of the break-away connector 300 corresponds to a state wherein thecomponents of the first body member 310 are assembled but the first bodymember 310 and the second body member 320 are not coupled.

With reference to FIG. 3B, the first body member 310 may comprise afirst portion 311, a second portion 312, and a valve 313. The valve 313may be disposed within the first body member 310 (i.e., between each ofthe first portion 311 and the second portion 312). In some embodiments,the valve 313 may be disposed within the second body member 320. In someother embodiments, the break-away connector 300 may comprise more thanone valve 313. For example, a first valve may be disposed within thefirst body member 310 and a second valve may be disposed within thesecond body member 320. As discussed above regarding the break-awayconnector 100, the first portion 311 and the second portion 312 may becoupled to each other by at least one of a compression fit, a snap fit,an adhesive, or another suitable coupling mechanism. In someembodiments, the first body member 310 may comprise only a singleportion or another suitable number of portions.

The first body member 310, as shown, comprises a coupling end portion314 and a break-away end portion 315. The coupling end portion 314 canbe disposed at an end of the first body member 310 opposite from thebreak-away end portion 315. As illustrated, the coupling end portion 314comprises a male connector. As stated above, however, other suitablecoupling mechanisms are also within the scope of this disclosure. Thefirst body member 310 can further comprise one or more resilient arms316. For example, the first body member 310 can comprise four resilientarms 316. Furthermore, the one or more resilient arms 316 may compriseone or more ridge portions or raised portions 317. For example, a firstresilient arm 316 can comprise a first ridge portion 317, a secondresilient arm 316 can comprise a second ridge portion 317, and so on.Additionally, one or more slots 318 may be disposed adjacent, between,or within the one or more resilient arms 316.

The second body member 320 can also comprise a coupling end portion 324and a break-away end portion 325, wherein the coupling end portion 324can be disposed at an end of the second body member 320 opposite fromthe break-away end portion 325. As depicted, the coupling end portion324 comprises a female connector. Again, as stated above, other suitablecoupling mechanisms are also within the scope of this disclosure. Thebreak-away end portion 325 of the second body member 320 can compriseone or more ridge portions or raised portions 327. For example, thebreak-away end portion 325 of the second body member 320 can comprisefour ridge portions 327 disposed around at least a portion of thecircumference of the break-away end portion 325. Furthermore, one ormore ribs 328 can be disposed adjacent or between the one or more ridgeportions 327. In certain embodiments, the one or more ribs 328 may beconfigured to be at least partially disposed within at least a portionof the one or more slots 318 upon coupling of the first and second bodymembers 310, 320.

In various embodiments, the one or more ridge portions 317 of the firstbody member 310 may be configured to engage or interact with the one ormore ridge portions 327 of the second body member 320 (i.e., uponcoupling of the first and second body members 310, 320).

The break-away connector 300, as shown, can further comprise a collarmember 340. As illustrated in FIG. 3B, the collar member 340 can includea plurality of threads 341, wherein the threads 341 are disposed on aninterior surface of the collar member 340. Furthermore, the collarmember 340 can be disposable around at least a portion of the first bodymember 310, wherein the plurality of collar member threads 341 may beconfigured to engage or interact with a plurality of threads 319disposed on an exterior surface of the first portion 311 of the firstbody member 310. In some embodiments, the threads 319 may be disposed ona different portion of the first body member 310 (e.g., the secondportion 312). In some other embodiments, a first portion of the threads319 may be disposed on the first portion 311 and a second portion of thethreads 319 may be disposed on the second portion 312. In yet some otherembodiments, the threads 319, or at least a portion of the threads 319,may be disposed on the second body member 320 and the collar member 340may be disposable around at least a portion of the second body member320.

In certain embodiments, the collar member 340 may further comprise afirst portion of a ratchet assembly (not shown). Furthermore, a secondportion of the ratchet assembly may be disposed on at least a portion ofthe first body member 310 and/or the second body member 320. In someembodiments, a plurality of teeth of the first portion of the ratchetassembly may engage or interact with a plurality of detents of thesecond portion of the ratchet assembly, or vice versa. The ratchetassembly may aid in the continuous or incremental adjustment or tuningof the collar member 340, as discussed below. For example, rotation ofthe collar member 340 comprising a first or second portion of theratchet assembly may generate one or more “clicks” that may be feltand/or heard by the user. Thus, the user may be able to adjust a degreeor level of coupling strength of the break-away connector 300 accordingto rotating the collar member 340 through a desired or predeterminednumber of “clicks.” In some embodiments, the ratchet assembly may limitor minimize accidental rotation of the collar member 340 and/or theratchet assembly may limit or minimize rotation of the collar member 340in at least one direction.

In various embodiments, the collar member 340 and/or the break-awayconnector 300 may comprise one or more indicia that may indicate orindex the coupling strength or tightness configuration in which thebreak-away connector 300 is disposed. The collar member 340 may comprisean indicium (e.g., a tick mark) and a portion of the break-awayconnector 300 adjacent the collar member 340 may comprise a plurality ofindicia that, when aligned with the indicium of the collar member 340,can indicate each of the plurality of coupling strengths of thebreak-away connector 300. For example, alignment of the indicium on thecollar member 340 with a first indicium on a portion of the break-awayconnector 300 adjacent the collar member 340 may indicate that thebreak-away connector 300 is in a high force configuration, whilealignment of the indicium on the collar member 340 with a fifth indiciumon the portion of the break-away connector 300 adjacent the collarmember 340 may indicate that the break-away connector 300 is in a highforce configuration. Furthermore, alignment of the indicium on thecollar member 340 with a second indicium, third indicium, or fourthindicium on the portion of the break-away connector 300 adjacent thecollar member 340 can indicate that the break-away connector 300 isdisposed in configurations of increasing tightness or strength, forexample, from a first/low force configuration (e.g., setting “1”) to afifth/high force configuration (e.g., setting “5”) and each of theincrementally increasing strengths in between (e.g., settings “2”, “3”,and “4”). Other numbers of indicia and/or settings are also within thescope of this disclosure. Such indicia that can indicate or index acoupling strength or tightness configuration in which a break-awayconnector is disposed may analogously and/or equally apply to allembodiments of the break-away connector as described herein (e.g.,break-away connectors 300, 400, 600).

FIG. 3C is an exploded cross-sectional side view of the break-awayconnector 300 of FIG. 3A. The first body member 310 comprises aplurality of resilient arms 316. As stated above, in some otherembodiments, the first body member 310 may comprise one, two, three,four, five, six, or more resilient arms. A slot 318 can be at leastpartially disposed between each of the resilient arms 316. As discussedabove, the second body member 320 can comprise one or more ribs 328 (seeFIGS. 3A and 3B). In some embodiments, at least a portion of at leastone of the ribs 328 can be configured to be disposed within at least aportion of the slots 318 upon coupling of the first and second bodymembers 310, 320. The disposition of at least a portion of the rib 328within at least a portion of at least one slot 318 may be configured tosubstantially limit or minimize rotation of the first body member 310 inrelation to the second body member 320 around a longitudinal axis of thebreak-away connector 300 when the first and second body members 310, 320are coupled to one another.

FIG. 3D is a cross-sectional side view of the break-away connector 300of FIG. 3A, in the coupled state. With reference to each of FIGS. 3C and3D, the first body member 310 can comprise a plurality of resilient arms316, wherein each resilient arm 316 comprises a ridge portion 317.Likewise, the second body member 320 can comprise a plurality of ridgeportions 327. As described above, the break-away connector 300 maycomprise one, two, three, four, five, or more resilient arms, eachresilient arm comprising a ridge portion. Additionally, the break-awayconnector 300 may comprise one, two, three, four, five, or more ridgeportions 327 of the second body member 320. Each of the plurality ofridge portions 317, 327 of the first body member 310 and/or the secondbody member 320, respectively, may have different heights or profilesand/or a combination of heights or profiles such that the break-awayconnector 300 may comprise a variety of coupling strengths ortightnesses. Accordingly, in certain embodiments, the break-awayconnector 300 may comprise one, two, three, four, five, or more couplingstrength or tightness configurations.

With continued reference to FIG. 3D, the collar member 340 may beconfigured to limit or minimize radial movement of the one or moreresilient arms 316 outward relative to the longitudinal axis of thebreak-away connector 300. For example, as the collar member 340 isthreadably rotated around at least a portion of the first body member310, the collar member 340 can be displaced toward the coupling endportion 314 of the first body member 310 and consequently a lesserportion of the collar member 340 may be disposed at or adjacent the oneor more resilient arms 316. As depicted, the collar member 340 comprisesa first end portion 343 and a second end portion 344. The collar member340 further comprises a lumen 342 disposed within the collar member 340between at least the first end portion 343 and the second end portion344. The diameter of the lumen 342 of the collar member 340 adjacent thefirst end portion 343, as shown, is greater than the diameter of thelumen 342 adjacent the second end portion 344. The interior surface ofthe collar member 340 adjacent the second end portion 344 can form aresilient arm engagement surface 345. When the resilient arm engagementsurface 345 is disposed at or adjacent a base portion 337 of each of theresilient arms 316 (i.e., in a second position), as depicted in FIG. 3D,the length of the portion of each of the resilient arms 316 that is notdisposed adjacent the interior surface of the collar member 340 isgreater than when the collar member 340 is disposed at or adjacent anend portion 338 of each of the resilient arms 316 (i.e., in a firstposition). Stated another way, displacement of the collar member 340longitudinally with respect to the resilient arms 316 may increase ordecrease the effective length of the resilient arms 316.

The effective length of the resilient arms 316 may correlate to theforce needed to couple or decouple the first body member 310 and thesecond body member 320. Interaction of the ridge portions 317 on theresilient arms 316 and the ridge portions 327 on the second body member320 during coupling or uncoupling tend to displace the resilient arms316 radially outward. The longer the effective length of the resilientarms 316, the relatively less force required to displace the ridgeportions 317 of the resilient arms 316 radially outward. Shortening theeffective length of the resilient arms 316 increases the necessaryforce. Thus displacement of the collar member 340 may allow foradjustment of the coupling or uncoupling force associated with thebreak-away connector 300, even in embodiments where the ridge portions317 have a uniform height around the circumference of the first bodymember 310 and the ridge portions 327 of the second body member 320 havea uniform height around the circumference of the second body member 320.

Stated another way, the resilient arms 316 may be understood ascantilever springs, allowing for radial displacement to permit the ridgeportions 317 of the resilient arms 316 to be displaced longitudinallypast the ridge portions 327 of the second body member 320. The longerthe effective length of the cantilever springs, the less force is neededto displace the free end of the cantilever spring a particular distance.Adjustment of the collar member 340 thus adjusts the effective length ofthe cantilever springs and thus adjusts the force needed to couple ordecouple the break-away connector 300.

In the configuration as depicted in FIG. 3D (e.g., the secondconfiguration or the second setting), wherein the resilient armengagement surface 345 is disposed at or adjacent the base portion 337of each of the resilient arms 316, each of the resilient arms 316 isless restricted and more freely able to be biased or to extend radiallyoutward relative to the longitudinal axis of the break-away connector300 such that each of the ridge portions 317 of the first body member310 can be easily, or more easily, disengaged or uncoupled from theridge portions 327 of the second body member 320. In contrast, when theresilient arm engagement surface 345 is disposed at or adjacent the endportion 338 of each of the resilient arms 316 (e.g., in the firstconfiguration or the first setting), each of the resilient arms 316 ismore restricted and less freely able to be biased or to extend radiallyoutward relative to the longitudinal axis of the break-away connector300, such that the ridge portions 317 of the first resilient arms 316can be less easily disengaged or uncoupled from the ridge portions 327of the second body member 320. Stated another way, it may be moredifficult to disengage or uncouple the ridge portions 317 from the ridgeportions 327 when the collar member 340 is in the first positioncompared to when the collar member 340 is in the second position.

In some embodiments, the collar member 340 may be continuously orincrementally adjustable between each of the first position and thesecond position such that the strength of the coupling of the first andsecond body members 310, 320, or a degree or level of coupling strengthbetween the first and second body members 310, 320, is continuously orincrementally adjustable or tunable. In some embodiments, when thecollar member 340 is in the first position the break-away connector 300can be in the first configuration and when the collar member 340 is inthe second position the break-away connector 300 can be in the secondconfiguration. The first configuration, as described above, may be ahigh force configuration and the second configuration, as describedabove, may be a low force configuration. For example, a practitioneruncoupling the first and second body members 310, 320 may apply, exert,or utilize a greater amount of force (i.e., mechanical force) touncouple the first and second body members 310, 320 when the break-awayconnector 300 is in the first configuration in comparison to when thebreak-away connector 300 is in the second configuration.

FIG. 4A is a perspective view of a break-away connector 400, in acoupled state, and FIG. 4B is an exploded view of the break-awayconnector 400 of FIG. 4A. As illustrated, the break-away connector 400can comprise a first body member 410 and a second body member 420.Analogous to the break-away connectors 100, 200, 300, the first andsecond body members 410, 420 of the break-away connector 400 arecoupleable. As discussed above in reference to the break-away connector200, the break-away connector 400 does not include a valve. In someembodiments, however, the break-away connector 400 may comprise one ormore valves. For example, a first valve may be disposed within at leasta portion of the first body member 410 and a second valve may bedisposed within at least a portion of the second body member 420.

The first body member 410, as shown, comprises a coupling end portion414 and a break-away end portion 415. As illustrated, the coupling endportion 414 comprises a female connector. Again, as stated above, othersuitable coupling mechanisms are also within the scope of thisdisclosure. The first body member 410 can further comprise one or moreresilient arms 416. For example, the first body member 410 can comprisefour resilient arms 416. Furthermore, the one or more resilient arms 416may comprise one or more ridge portions or raised portions 417. Forexample, a first resilient arm 416 can comprise a first ridge portion417, a second resilient arm 416 can comprise a second ridge portion 417,and so on. Additionally, one or more slots 418 may be disposed adjacent,between, or within the one or more resilient arms 416.

The second body member 420 can also comprise a coupling end portion 424and a break-away end portion 425. As depicted, the coupling end portion424 comprises a male connector. Again, as discussed above, othersuitable coupling mechanisms are also within the scope of thisdisclosure. The break-away end portion 425 of the second body member 420can comprise one or more ridge portions or raised portions 427. Forexample, the break-away end portion 425 of the second body member 420can comprise four ridge portions 427 disposed around at least a portionof the circumference of the break-away end portion 425. Furthermore, oneor more ribs 428 may be disposed adjacent or between the one or moreridge portions 427. In certain embodiments, the one or more ribs 428 maybe configured to be at least partially disposed within at least aportion of the one or more slots 418 upon coupling of the first andsecond body members 410, 420.

In various embodiments, the one or more ridge portions 417 of the firstbody member 410 may be configured to engage or interact with the one ormore ridge portions 427 of the second body member 420 (i.e., uponcoupling of the first and second body members 410, 420).

The break-away connector 400, as shown, can further comprise a collarmember 440. As illustrated in FIG. 4B, the collar member 440 can includea plurality of threads 441, wherein the threads 441 are disposed on aninterior surface of the collar member 440. Furthermore, the collarmember 440 is disposable around at least a portion of the first bodymember 410, wherein the plurality of collar member threads 441 may beconfigured to engage or interact with a plurality of threads 419disposed on an exterior surface of the first body member 410. In someembodiments, the threads 419 may be disposed on a different portion ofthe first body member 410. In some other embodiments, the threads 419,or at least a portion of the threads 419, may be disposed on the secondbody member 420 and the collar member 440 may be disposable around atleast a portion of the second body member 420 or each of the first andsecond body members 410, 420.

In some embodiments, the collar member 440 may further comprise one ormore openings or windows 446. The openings 446 may allow or permit auser to access or view various components of the break-away connector400 that are disposed in at least a portion of a lumen 442 of the collarmember 440. In some embodiments, such a configuration may aid a user inadjusting or tuning a coupling strength of the break-away connector 400.

FIG. 4C is an exploded cross-sectional side view of the break-awayconnector 400 of FIG. 4B. As depicted, the first body member 410comprises a plurality of resilient arms 416. As stated above, in someother embodiments, the first body member 410 may comprise one, two,three, four, five, six, or more resilient arms. A slot 418 can be atleast partially disposed between two of the resilient arms 416. Asdiscussed above, the second body member 420 can comprise a plurality ofribs 428. In some embodiments, at least a portion of at least one of theribs 428 can be configured to be disposed within at least a portion ofat least one of the slots 418 upon coupling of the first and second bodymembers 410, 420. The disposition of at least a portion of the rib 428within at least a portion of at least one slot 418 may be configured tosubstantially limit or minimize rotation of the first body member 410 inrelation to the second body member 420 around a longitudinal axis of thebreak-away connector 400 when the first and second body members 410, 420are coupled to one another.

FIG. 4D is a cross-sectional side view of the break-away connector 400of FIG. 4A, in the coupled state. With reference to each of FIGS. 4C and4D, the first body member 410 can comprise a plurality of resilient arms416, wherein each resilient arm 416 comprises a ridge portion 417.Likewise, the second body member 420 can comprise a plurality of ridgeportions 427. As described above, the break-away connector 400 maycomprise one, two, three, four, five, or more resilient arms, eachresilient arm comprising a ridge portion. Additionally, the break-awayconnector 400 may comprise one, two, three, four, five, or more ridgeportions 427 of the second body member 420. Each of the plurality ofridge portions 417, 427 of the first body member 410 and/or the secondbody member 420, respectively, may have different heights or profilesand/or a combination of heights or profiles such that the break-awayconnector 400 may comprise a variety of coupling strengths ortightnesses. Accordingly, in certain embodiments, the break-awayconnector 400 may comprise one, two, three, four, five, or more couplingstrength or tightness configurations.

With continued reference to FIG. 4D, the collar member 440 may beconfigured to limit or minimize radial movement of the one or moreresilient arms 416 outward relative to the longitudinal axis of thebreak-away connector 400. For example, as the collar member 440 isthreadably rotated around the first body member 410, the collar member440 may be displaced toward the coupling end portion 414 of the firstbody member 410 and consequently a lesser portion of the collar member440 may be disposed at or adjacent the one or more resilient arms 416.As depicted, the collar member 440 comprises a first end portion 443 anda second end portion 444. The collar member 440 further comprises alumen 442 disposed within the collar member 440 between at least thefirst end portion 443 and the second end portion 444. The interiorsurface of the collar member 440 adjacent the first end portion 443 canform a resilient arm engagement surface 445. When the resilient armengagement surface 445 is disposed at or adjacent a base portion 437 ofeach of the resilient arms 416 (i.e., in a second position), the lengthof the portion of each of the resilient arms 416 that is not disposedadjacent an interior surface of the collar member 440 is greater thanwhen the collar member 440 is disposed at or adjacent an end portion 438of each of the resilient arms 416 (i.e., in a first position).

In the second configuration or the second setting, wherein the resilientarm engagement surface 445 is disposed at or adjacent the base portion437 of each of the resilient arms 416, each of the resilient arms 416 isless restricted and more freely able to be biased or to extend radiallyoutward relative to the longitudinal axis of the break-away connector400 such that each of the ridge portions 417 of the first body member410 can be easily, or more easily, disengaged or uncoupled from theridge portions 427 of the second body member 420. In contrast, when theresilient arm engagement surface 445 is disposed at or adjacent the endportion 438 of each of the resilient arms 416 (e.g., in the firstconfiguration or the first setting), each of the resilient arms 416 ismore restricted and less freely able to be biased or to extend radiallyoutward relative to the longitudinal axis of the break-away connector400, such that the ridge portions 417 of the first resilient arms 416can be less easily disengaged or uncoupled from the ridge portions 427of the second body member 420. Stated another way, it may be moredifficult to disengage or uncouple the ridge portions 417 from the ridgeportions 427 when the collar member 440 is in the first positioncompared to when the collar member 440 is in the second position.

Analogous to the embodiment of FIGS. 3A-3D, adjustment of the collarmember 440 may thus adjust the effective length of the resilient arms416 to adjust the force associated with coupling or uncoupling thebreak-away connector 400.

In some embodiments, the collar member 440 may be continuously orincrementally adjustable between each of the first position and thesecond position such that the strength of the coupling of the first andsecond body members 410, 420, or a level of coupling strength betweenthe first and second body members 410, 420, is continuously orincrementally adjustable or tunable. In some embodiments, when thecollar member 440 is in the first position the break-away connector 400can be in the first configuration and when the collar member 440 is inthe second position the break-away connector 400 can be in the secondconfiguration. The first configuration, as described above, may be ahigh force configuration and the second configuration, as describedabove, may be a low force configuration. For example, a practitioneruncoupling the first and second body members 410, 420 may apply, exert,or utilize a greater amount of force (i.e., mechanical force) touncouple the first and second body members 410, 420 when the break-awayconnector 400 is in the first configuration in comparison to when thebreak-away connector 400 is in the second configuration.

FIG. 5A is a perspective view of a break-away connector 500 in a coupledstate, and FIG. 5B is an exploded view of the break-away connector 500of FIG. 5A. As illustrated, the break-away connector 500 can comprise afirst body member 510 and a second body member 520. Analogous to thebreak-away connectors 100, 200, 300, 400, the first and second bodymembers 510, 520 of the break-away connector 500 are coupleable. Also,the uncoupled state of the break-away connector 500 corresponds to astate wherein the components of each of the first body member 510 andthe second body member 520 are assembled but the first body member 510and the second body member 520 are not coupled. In comparison to thebreak-away connector 100, for example, the polarity of the valve 513 andthe coupling end portions 514, 524 of the break-away connector 500 isswitched or inverted.

Again, in some embodiments, the first body member 510 can be coupled tothe second body member 520, and vice versa, by a user. With reference toFIG. 5B, the first body member 510 may comprise a first portion 511, asecond portion 512, and a valve 513. The valve 513 may be disposedwithin the first body member 510 (i.e., between each of the firstportion 511 and the second portion 512). As discussed above regardingthe break-away connectors 100, 300, the first portion 511 and the secondportion 512 may be coupled to each other by at least one of acompression fit, a snap fit, an adhesive, or another suitable couplingmechanism. The second body member 520 may comprise a first portion 521and a seal member 532. The seal member 532 may be configured to becoupled to the first portion 521 as illustrated in FIGS. 5C and 5D. Insome embodiments, the first body member may comprise only a singleportion or another suitable number of portions. In certain embodiments,the second body member may comprise two portions or another suitablenumber of portions.

The first body member 510 can further comprise a coupling end portion514 and a break-away end portion 515. As depicted, the coupling endportion 514 may be disposed at an end of the first body member 510opposite from the break-away end portion 515. The coupling end portion514, as illustrated, comprises a female connector. As discussed above,however, the coupling end portion 514 may comprise any suitable couplingmechanism. The first body member 510 may further comprise one or moreresilient arms. For example, the first body member 510 may comprise afirst resilient arm 516 a and a second resilient arm 516 b, wherein theresilient arms 516 a, 516 b extend longitudinally away from the couplingend portion 514 of the first body member 510. Furthermore, the one ormore resilient arms 516 a, 516 b may comprise one or more ridge portionsor raised portions. For example, the first resilient arm 516 a maycomprise a first ridge portion 517 a (see FIGS. 5C and 5D) extendinginwardly toward a longitudinal axis of the break-away connector 500, andthe second resilient arm 516 b may comprise a second ridge portion 517 bextending inwardly toward the longitudinal axis of the break-awayconnector 500. One or more slots may be disposed adjacent, between, orwithin the one or more resilient arms 516 a, 516 b. For example, asillustrated, a first slot 518 a and a second slot (not visible in thisview) can be disposed between each of the first resilient arm 516 a andthe second resilient arm 516 b. In some embodiments, the break-awayconnector 500 may comprise one, two, three, four, five, or moreresilient arms, ridge portions, and/or slots.

The second body member 520 can also comprise a coupling end portion 524and a break-away end portion 525, wherein the coupling end portion 524may be disposed at an end of the second body member 520 opposite fromthe break-away end portion 525. The coupling end portion 524, asillustrated, comprises a male connector. Again, as discussed above, thecoupling end portion 524 may also comprise any suitable couplingmechanism. The break-away end portion 525 of the second body member 520can comprise one or more ridge portions or raised portions. For example,the break-away end portion 525 can comprise a first ridge portion 527 aand a second ridge portion 527 b (see FIGS. 5C and 5D). One or more ribsmay also be disposed adjacent or between the one or more ridge portions527 a, 527 b. For example, the break-away end portion 525 may comprise afirst rib 528 a and a second rib 528 b. In certain embodiments, the oneor more ribs 528 a, 528 b may be configured to be at least partiallydisposed within at least a portion of the one or more slots 518 a uponcoupling of the first and second body portions 510, 520.

In various embodiments, the one or more ridge portions 517 a, 517 b ofthe first body member 510 may be configured to engage or interact withthe one or more ridge portions 527 a, 527 b of the second body member520. Additionally, the first and second body members 510, 520 may becoupleable in at least two configurations or settings. In someembodiments, a greater force may be required to uncouple the first bodymember 510 from the second body member 520 when the break-away connector500 is in a first configuration or setting in comparison to when thebreak-away connector 500 is in a second configuration or setting. Forexample, a practitioner uncoupling the first body member 510 from thesecond body member 520 may apply, exert, or utilize a greater amount offorce (i.e., mechanical force) to uncouple the first body member 510from the second body member 520 when the break-away connector 500 is inthe first configuration than when the break-away connector 500 is in thesecond configuration. In some other embodiments, the first and secondbody members 510, 520 may be coupleable in three, four, five, or moreconfigurations or settings, wherein each configuration or setting maycomprise a different level of strength or tightness.

As stated above, the polarity of the valve 513 and the coupling endportions 514, 524 of the break-away connector 500 can be switched orinverted in comparison to the break-away connector 100. In someembodiments, the first body member 512, which comprises the valve 513,may be coupled (e.g., by a practitioner or a user) more proximally thanthe second body member 520 to a medical device such as a drainage bag ora collection bag. When the break-away connector 500 is in use (i.e.,coupled to a patient via a catheter to drain a volume of a fluid fromthe patient), the valve 513 may be disposed in the first body member512. Stated another way, the valve 513 may be disposed on the drainagebag “side” of the break-away connector 500. In contrast, a first end ofa catheter can be coupled to the second body member 520 and a second endof the catheter can be coupled to or disposed within a patient. Statedanother way, the catheter may be disposed on the patient “side” of thebreak-away connector 500. In such a configuration, the catheter maycontinue to drain fluid from the patient (i.e., onto the floor) even ifthe first body member 510 and the second body member 520 of thebreak-away connector 500 decouple.

In some other embodiments, the first body member 512, which comprisesthe valve 513, may be coupled more distally than the second body member520 to a medical device such as a drainage bag or a collection bag.Stated another way, the valve 513 may be disposed on the “patient” sideof the break-away connector 500. Furthermore, a first end of a cathetermay be coupled to the first body member 512 and a second end of thecatheter may be coupled to or disposed within a patient. In such aconfiguration, the catheter may be configured such that fluid flow fromthe patient is inhibited, limited, or minimized if the first body member510 and the second body member 520 of the break-away connector 500decouple. Other configurations of the break-away connector 500 and thevalve 513 are also within the scope of this disclosure. For example, thebreak-away connector 500 may comprise two valves, a first valve disposedon the drainage bag “side” of the break-away connector 500 and a secondvalve disposed on the patient “side” of the break-away connector 500. Insuch a configuration, flow of fluid from each of the patient and thedrainage bag may be inhibited, limited, or minimized upon uncoupling ofthe first body member 510 and the second body member 520 of thebreak-away connector 500.

FIG. 5C is an exploded cross-sectional side view of the break-awayconnector 500 of FIG. 5A. As depicted, the first body member 510 cancomprise two resilient arms 516 a, 516 b. Additionally, the slot 518 acan be a least partially disposed between each of the two resilient arms516 a, 516 b. As discussed above, the second body member 520 cancomprise one or more ribs 528 a, 528 b (see FIGS. 5A and 5B). In certainembodiments, at least a portion of the one or more ribs 528 a, 528 b canbe configured to be disposed within at least a portion of the one ormore slots 518 a when the first body member 510 is coupled to the secondbody member 520, such that rotation of the first body member 510 inrelation to the second body member 520 around a longitudinal axis of thebreak-away connector 500 may be substantially limited or minimized.Stated another way, the engagement or interaction of the first bodymember 510 with the second body member 520, via the slots, resilientarms, and ribs, may substantially limit or minimize displacement orrotation of the first body member 510 and the second body member 520between each of the first configuration or setting and the secondconfiguration or setting, and vice versa. Still further, interaction ofthe one or more ribs 528 a, 528 b (see FIGS. 5A and 5B) and a portion ofthe one or more slots 518 a may facilitate alignment of the first bodymember 510 and the second body member 520 when coupled.

In some other embodiments, the first body member 510 may comprise onlyone resilient arm, wherein the one resilient arm may comprise a singleslot. Furthermore, the second body member 520 may comprise only one rib,wherein at least a portion of the rib is configured to be disposedwithin at least a portion of the slot when the first and second bodymembers 510, 520 are coupled to each other, such that rotation of thefirst body member 510 in relation to the second body member 520 aroundthe longitudinal axis of the break-away connector 500 is substantiallylimited or minimized. As discussed above, engagement or interaction ofthe rib with the slot may substantially limit or minimize rotation ofthe first body member 510 in relation to the second body member 520, orvice versa.

As shown in FIG. 5C, the first body member 510 can further comprise afirst lumen 505 disposed within at least a portion of the first bodymember 510, wherein the first lumen 505 is configured to provide fluidcommunication between a first end and a second end of the first bodymember 510. The second body member 520 can further comprise a secondlumen 506 disposed within at least a portion of the second body member520, wherein the second lumen 506 is configured to provide fluidcommunication between a first end and a second end of the second bodymember 520. Furthermore, when the first and second body members 510, 520are coupled to one another, the first lumen 505 may be configured to bein fluid communication with the second lumen 506 (i.e., the first lumen505 may be substantially aligned with the second lumen 506).

The break-away connector 500, as illustrated, may further comprise theseal member 532, wherein the seal member 532 is configured tosubstantially limit or minimize fluid communication between each of thefirst lumen 505 and/or the second lumen 506 with an exterior environmentof the break-away connector 500 when the first and second body members510, 520 are coupled to one another (i.e., when the seal member 532 iscoupled to the second body member 520 as in FIG. 5D). For example, theseal member 532 may be configured to limit or minimize leakage of afluid from within the break-away connector 500 to the exteriorenvironment of the break-away connector 500. In certain embodiments, theseal member 532 may be an O-ring or another suitable sealing mechanism.

FIG. 5D is a cross-sectional side view of the break-away connector 500of FIG. 5A in the coupled state. With reference to each of FIGS. 5C and5D, the first body member 510 can comprise the first resilient arm 516 aand the second resilient arm 516 b. As illustrated, the height orprofile of the first ridge portion 517 a of the first resilient arm 516a can be greater than the height or profile of the second ridge portion517 b of the second resilient arm 516 b. Likewise, the second bodymember 520 can comprise the first ridge portion 527 a and the secondridge portion 527 b, wherein the height or profile of the first ridgeportion 527 a can be greater than the height or profile of the secondridge portion 527 b. As described above, the break-away connector 500may comprise one, two, three, four, five, or more resilient arms, eachresilient arm comprising a ridge portion. Additionally, the break-awayconnector 500 may comprise one, two, three, four, five, or more ridgeportions of the second body member 520. Each of the plurality of ridgeportions 517, 527 of the first body member 510 and/or the second bodymember 520, respectively, may have different heights or profiles and/ora combination of heights or profiles such that the break-away connector500 may comprise a variety of coupling strengths or tightnesses.Accordingly, in certain embodiments, the break-away connector 500 maycomprise one, two, three, four, five, or more coupling strength ortightness configurations.

In some embodiments, the first configuration or setting may be a highforce configuration or setting. In the first configuration or the highforce configuration, the first ridge portion 517 a of the firstresilient arm 516 a may engage or interact with the first ridge portion527 a of the second body member 520 (the configuration or setting shownin FIG. 5D). In such a configuration, two high profile ridge portions(e.g., the first ridge portions 517 a, 527 a) may engage or interactwith each other. In certain embodiments, the second configuration may bea low force configuration. In the second configuration or the low forceconfiguration, the first ridge portion 517 a of the first resilient arm516 a may engage or interact with the second ridge portion 527 b of thesecond body member 520. In such a configuration, a high profile ridgeportion (e.g., the first ridge portion 517 a) may engage or interactwith a low profile ridge portion (e.g., the second ridge portion 527 b).In certain embodiments, uncoupling of a break-away connector 500 whentwo high profile ridge portions are engaged with each other may utilizeor require a greater force than uncoupling of the break-away connector500 when a high profile ridge portion is engaged with a low profileridge portion.

With reference again to FIGS. 5A and 5B, the first resilient arm 516 acan comprise a first indicium 530 a (e.g., an “H” for high or anothersuitable indicium), and a portion of the second body member 520 adjacentthe first ridge portion 527 a can comprise a second indicium 530 b(e.g., an elongate arrowhead or another suitable indicium). When thefirst indicium 530 a and the second indicium 530 b are substantiallyaligned (i.e., upon coupling of the first and second body members 510,520), the break-away connector 500 can be in the high forceconfiguration or setting. Conversely, when the first indicium 530 a issubstantially aligned with a portion of the second body member 520opposite of the second indicium 530 b, the break-away connector 500 canbe in the low force configuration or setting. Again, interaction of theone or more ribs 528 a, 528 b and a portion of the one or more slots 518a may facilitate alignment of the first body member 510 and the secondbody member 520 when coupled and when selecting between the high forceconfiguration and the low force configuration.

Referring again to FIG. 5D, the valve 513 can be disposed within atleast a portion of the first lumen 505. In some embodiments, the valve513 may be disposed within at least a portion of the second lumen 506.In some other embodiments, a first valve may be disposed within thefirst lumen 505 and a second valve may be disposed within the secondlumen 506.

As illustrated, the break-away connector 500 may comprise a first valveengagement member 534 disposed within the first lumen 505 and/or coupledto the first body member 510. The break-away connector 500 may alsocomprise a second valve engagement member 535 disposed within the secondlumen 506 and/or coupled to the second body member 520. As illustrated,the first valve engagement member 534 comprises a post-like memberconfigured to engage a center portion of a first surface of the valve513. In some other embodiments, the first valve engagement member 534may be substantially conical, substantially semispherical, or anothersuitable shape. In contrast, the second valve engagement member 535, asillustrated, comprises a raised, substantially annular surfaceconfigured to engage a portion of a second, or opposite, surface of thevalve 513 disposed radially in relation to the center portion of thevalve 513. In some embodiments, the second valve engagement member 535may be substantially square, substantially triangular, or anothersuitable shape. The engagement or interaction of the first and secondvalve engagement members 534, 535 with the valve 513 may be configuredto open the valve 513 when the first and second body members 510, 520are coupled to one another. For example, the first and second valveengagement members 534, 535 may be displaced toward each other. Thefirst valve engagement member 534 may be configured to displace at leasta portion of the central portion of the valve 513 toward the secondvalve engagement member 535, and the second valve engagement member 535may be configured to displace at least a portion of the portion of thevalve 513 radially disposed relative to the central portion of the valve513 toward the first valve engagement member 534. Such displacement ofthe above-described portions of the valve 513 may result in thetransition of the valve 513 from the closed configuration to the openconfiguration.

Other mechanisms of opening the valve 513 are also within the scope ofthis disclosure. For example, the break-away connector 500 may includeonly one valve engagement member (i.e., similar to the first valveengagement member 534). Engagement or interaction of the one such valveengagement member with the valve 513 may result in the transition of thevalve 513 from the closed configuration to the open configuration. Incertain embodiments, the valve 513 may be formed from a resilientmaterial (e.g., a polymeric material or another suitable material) suchthat the valve 513 is also configured to transition from the openconfiguration to the closed configuration upon disengagement of the oneor more valve engagement members from the valve 513. With reference toFIG. 5D, the valve 513 can further comprise an aperture 536 (e.g., aslit), wherein the aperture 536 may be configured to transition from aclosed configuration to an open configuration upon engagement betweenthe one or more valve engagement members 534, 535 and the valve 513.Furthermore, the aperture 536 may also be configured to transition fromthe open configuration to the closed configuration or setting upondisengagement of the one or more valve engagement members 534, 535 fromthe valve 513.

In various embodiments, the coupling end portion 514 of the first bodymember 510 may be configured to be coupled to a first medical device,and the coupling end portion 524 of the second body member 520 may beconfigured to be coupled to a second medical device. For example, asdiscussed above, the break-away connector 500 may be configured for usein medical procedures including, but not limited to, drainage of avolume of a fluid from a patient and intravenous feeding of a patient.The break-away connector 500 may be configured to be coupled to a fluidcontainer such as an IV bag or a drainage bag. The break-away connector500 may also be configured to be coupled to a catheter, wherein at leasta portion of the catheter is disposed in a patient at an access site.The break-away connector 500 may be configured to function or operate asa flow regulator in combination with an IV assembly. In someembodiments, the break-away connector 500 may be configured to adjust arate of flow or passage of a fluid through the break-away connector 500.For example, the break-away connector 500 may further comprise a twistcontrol mechanism or a needle valve.

In certain embodiments, each of the coupling end portions 514, 524 maycomprise a different type of coupling mechanism. For example, thecoupling end portion 514 may comprise a male connector and the couplingend portion 524 may comprise a female connector. In another example, thecoupling end portion 514 may comprise a threaded coupling mechanism(e.g., a female connector or a male connector) and the coupling endportion 524 may comprise a compression fitting, a snap fitting, oranother type of suitable fitting. In various other embodiments, each ofthe coupling end portions 514, 524 may comprise the same type ofcoupling mechanism. For example, each of the coupling end portions 514,524 may comprise a female connector. In another example, each of thecoupling end portions 514, 524 may comprise a male connector. In yetanother example, each of the coupling end portions 514, 524 may comprisea compression fitting, a snap fitting, or another type of suitablefitting.

FIG. 6A is a perspective view of a break-away connector 600 in a coupledstate, and FIG. 6B is an exploded view of the break-away connector 600of FIG. 6A. As illustrated, the break-away connector 600 can comprise afirst body member 610 and a second body member 620. Analogous to thebreak-away connectors 100, 200, 300, 400, 500, the first and second bodymembers 610, 620 of the break-away connector 600 are coupleable. Also,the uncoupled state of the break-away connector 600 corresponds to astate wherein the components of each of the first body member 610 andthe second body member 620 are assembled but the first body member 610and the second body member 620 are not coupled. In comparison to thebreak-away connector 300, for example, the polarity of the valve 613 andthe coupling end portions 614, 624 of the break-away connector 600 isswitched or inverted.

With reference to FIG. 6B, the first body member 610 may comprise afirst portion 611, a second portion 612, and a valve 613. The valve 613may be disposed within the first body member 610 (i.e., between each ofthe first portion 611 and the second portion 612). In some embodiments,the valve 613 may be disposed within the second body member 620. In someother embodiments, the break-away connector 600 may comprise more thanone valve 613. For example, a first valve may be disposed within thefirst body member 610 and a second valve may be disposed within thesecond body member 620. As discussed above regarding the break-awayconnectors 100, 300, 500, the first portion 611 and the second portion612 may be coupled to each other by at least one of a compression fit, asnap fit, an adhesive, or another suitable coupling mechanism. Thesecond body member 620 may comprise a first portion 621 and a sealmember 632. The seal member 632 may be configured to be coupled to thefirst portion 621 (see FIGS. 6C and 6D). In some embodiments, the firstbody member 610 may comprise only a single portion or another suitablenumber of portions. In certain embodiments, the second body member 620may comprise two portions or another suitable number of portions.

The first body member 610, as shown, comprises a coupling end portion614 and a break-away end portion 615. The coupling end portion 614 canbe disposed at an end of the first body member 610 opposite from thebreak-away end portion 615. As illustrated, the coupling end portion 614comprises a female connector. As stated above, however, other suitablecoupling mechanisms are also within the scope of this disclosure. Thefirst body member 610 can further comprise one or more resilient arms616. For example, the first body member 610 can comprise four resilientarms 616. Furthermore, the one or more resilient arms 616 may compriseone or more ridge portions or raised portions 617. For example, a firstresilient arm 616 can comprise a first ridge portion 617, a secondresilient arm 616 can comprise a second ridge portion 617, and so on.Additionally, one or more slots 618 may be disposed adjacent, between,or within the one or more resilient arms 616.

The second body member 620 can also comprise a coupling end portion 624and a break-away end portion 625, wherein the coupling end portion 624can be disposed at an end of the second body member 620 opposite fromthe break-away end portion 625. As depicted, the coupling end portion624 comprises a male connector. Again, as stated above, other suitablecoupling mechanisms are also within the scope of this disclosure. Thebreak-away end portion 625 of the second body member 620 can compriseone or more ridge portions or raised portions 627. For example, thebreak-away end portion 625 of the second body member 620 can comprisetwo ridge portions 627 disposed around at least a portion of thecircumference of the break-away end portion 625. Furthermore, one ormore ribs 628 can be disposed adjacent or between the one or more ridgeportions 627. In certain embodiments, the one or more ribs 628 may beconfigured to be at least partially disposed within at least a portionof the one or more slots 618 upon coupling of the first and second bodymembers 610, 620.

In various embodiments, the one or more ridge portions 617 of the firstbody member 610 may be configured to engage or interact with the one ormore ridge portions 627 of the second body member 620 (i.e., uponcoupling of the first and second body members 610, 620).

The break-away connector 600, as shown, can further comprise a collarmember 640. As illustrated in FIG. 6B, the collar member 640 can includea plurality of threads 641, wherein the threads 641 are disposed on aninterior surface of the collar member 640. Furthermore, the collarmember 640 can be disposable around at least a portion of the first bodymember 610, wherein the plurality of collar member threads 641 may beconfigured to engage or interact with a plurality of threads 619disposed on an exterior surface of the first portion 611 of the firstbody member 610. In some embodiments, the threads 619 may be disposed ona different portion of the first body member 610 (e.g., the secondportion 612). In some other embodiments, a first portion of the threads619 may be disposed on the first portion 611 and a second portion of thethreads 619 may be disposed on the second portion 612. In yet some otherembodiments, the threads 619, or at least a portion of the threads 619,may be disposed on the second body member 620 and the collar member 640may be disposable around at least a portion of the second body member620.

In certain embodiments, the collar member 640 may further comprise afirst portion of a ratchet assembly (not shown). Furthermore, a secondportion of the ratchet assembly may be disposed on at least a portion ofthe first body member 610 and/or the second body member 620. In someembodiments, a plurality of teeth of the first portion of the ratchetassembly may engage or interact with a plurality of detents of thesecond portion of the ratchet assembly, or vice versa. The ratchetassembly may aid in the continuous or incremental adjustment or tuningof the collar member 640, as discussed above in reference to the collarmember 340. For example, rotation of the collar member 640 comprising afirst or second portion of the ratchet assembly may generate one or more“clicks” that may be felt and/or heard by the user. Thus, the user maybe able to adjust a degree or level of coupling strength of thebreak-away connector 600 according to rotating the collar member 640through a desired or predetermined number of “clicks.”

In some embodiments, the ratchet assembly may limit or minimizeaccidental or unintentional rotation of the collar member 640. Theratchet assembly may also limit or minimize rotation of the collarmember 640 in at least one direction. For example, a practitioner maydesire that the strength or tightness configuration in which thebreak-away connector 600 is disposed does not or cannot substantiallyadjust or change without input from the practitioner. Stated anotherway, in some embodiments, the break-away connector 600 may be configured(e.g., with a ratchet assembly) such that the collar member 640 and/orthe break-away connector 600 do not self-adjust or such thatself-adjustment is substantially inhibited, limited, or minimized.

FIG. 6C is an exploded cross-sectional side view of the break-awayconnector 600 of FIG. 6A. The first body member 610 comprises aplurality of resilient arms 616. As stated above, in some otherembodiments, the first body member 610 may comprise one, two, three,four, five, six, or more resilient arms. A slot 618 can be at leastpartially disposed between each of the resilient arms 616. As discussedabove, the second body member 620 can comprise one or more ribs 628 (seeFIGS. 6A and 6B). In some embodiments, at least a portion of at leastone of the ribs 628 can be configured to be disposed within at least aportion of the slots 618 upon coupling of the first and second bodymembers 610, 620. The disposition of at least a portion of the rib 628within at least a portion of at least one slot 618 may be configured tosubstantially limit or minimize rotation of the first body member 610 inrelation to the second body member 620 around a longitudinal axis of thebreak-away connector 600 when the first and second body members 610, 620are coupled to one another.

FIG. 6D is a cross-sectional side view of the break-away connector 600of FIG. 6A, in the coupled state. With reference to each of FIGS. 6C and6D, the first body member 610 can comprise a plurality of resilient arms616, wherein each resilient arm 616 comprises a ridge portion 617.Likewise, the second body member 620 can comprise a plurality of ridgeportions 627. As described above, the break-away connector 600 maycomprise one, two, three, four, five, or more resilient arms, eachresilient arm comprising a ridge portion. Additionally, the break-awayconnector 600 may comprise one, two, three, four, five, or more ridgeportions 627 of the second body member 620. Each of the plurality ofridge portions 617, 627 of the first body member 610 and/or the secondbody member 620, respectively, may have different heights or profilesand/or a combination of heights or profiles such that the break-awayconnector 600 may comprise a variety of coupling strengths ortightnesses. Accordingly, in certain embodiments, the break-awayconnector 600 may comprise one, two, three, four, five, or more couplingstrength or tightness configurations.

With continued reference to FIG. 6D, the collar member 640 may beconfigured to limit or minimize radial movement of the one or moreresilient arms 616 outward relative to the longitudinal axis of thebreak-away connector 600. For example, as the collar member 640 isthreadably rotated around at least a portion of the first body member610, the collar member 640 can be displaced toward the coupling endportion 614 of the first body member 610 and consequently a lesserportion of the collar member 640 may be disposed at or adjacent the oneor more resilient arms 616. As depicted, the collar member 640 comprisesa first end portion 643 and a second end portion 644. The collar member640 further comprises a lumen 642 disposed within the collar member 640between at least the first end portion 643 and the second end portion644. The diameter of the lumen 642 of the collar member 640 adjacent thefirst end portion 643, as shown, is greater than the diameter of thelumen 642 adjacent the second end portion 644. The interior surface ofthe collar member 640 adjacent the second end portion 644 can form aresilient arm engagement surface 645. When the resilient arm engagementsurface 645 is disposed at or adjacent a base portion 637 of each of theresilient arms 616 (i.e., in a second position), as depicted in FIG. 6D,the length of the portion of each of the resilient arms 616 that is notdisposed adjacent the interior surface of the collar member 640 isgreater than when the collar member 640 is disposed at or adjacent anend portion 638 of each of the resilient arms 616 (i.e., in a firstposition). Stated another way, displacement of the collar member 640longitudinally with respect to the resilient arms 616 may increase ordecrease the effective length of the resilient arms 616.

The effective length of the resilient arms 616 may correlate to theforce needed to couple or decouple the first body member 610 and thesecond body member 620. Interaction of the ridge portions 617 on theresilient arms 616 and the ridge portions 627 on the second body member620 during coupling or uncoupling tend to displace the resilient arms616 radially outward. The longer the effective length of the resilientarms 616, the relatively less force required to displace the ridgeportions 617 of the resilient arms 616 radially outward. Shortening theeffective length of the resilient arms 616 increases the necessaryforce. Thus displacement of the collar 640 may allow for adjustment ofthe coupling or uncoupling force associated with the break-awayconnector 600, even in embodiments where the ridge portions 617 have auniform height around the circumference of the first body member 610 andthe ridge portions 627 of the second body member 620 have a uniformheight around the circumference of the second body member 620.

In the configuration as depicted in FIG. 6D (e.g., the secondconfiguration or the second setting), wherein the resilient armengagement surface 645 is disposed at or adjacent the base portion 637of each of the resilient arms 616, each of the resilient arms 616 isless restricted and more freely able to be biased or to extend radiallyoutward relative to the longitudinal axis of the break-away connector600 such that each of the ridge portions 617 of the first body member610 can be easily, or more easily, disengaged or uncoupled from theridge portions 627 of the second body member 620. In contrast, when theresilient arm engagement surface 645 is disposed at or adjacent the endportion 638 of each of the resilient arms 616 (e.g., in the firstconfiguration or the first setting), each of the resilient arms 616 ismore restricted and less freely able to be biased or to extend radiallyoutward relative to the longitudinal axis of the break-away connector600, such that the ridge portions 617 of the first resilient arms 616can be less easily disengaged or uncoupled from the ridge portions 627of the second body member 620. Stated another way, it may be moredifficult to disengage or uncouple the ridge portions 617 from the ridgeportions 627 when the collar member 640 is in the first positioncompared to when the collar member 640 is in the second position.

In some embodiments, the collar member 640 may be continuously orincrementally adjustable between each of the first position and thesecond position such that the strength of the coupling of the first andsecond body members 610, 620, or a degree or level of coupling strengthbetween the first and second body members 610, 620, is continuously orincrementally adjustable or tunable. In some embodiments, when thecollar member 640 is in the first position the break-away connector 600can be in the first configuration and when the collar member 640 is inthe second position the break-away connector 600 can be in the secondconfiguration. The first configuration, as described above, may be ahigh force configuration and the second configuration, as describedabove, may be a low force configuration. For example, a practitioneruncoupling the first and second body members 610, 620 may apply, exert,or utilize a greater amount of force (i.e., mechanical force) touncouple the first and second body members 610, 620 when the break-awayconnector 600 is in the first configuration in comparison to when thebreak-away connector 600 is in the second configuration.

Methods related to use of break-away connectors, are also disclosedherein. In some embodiments, a method of coupling a break-away connectormay comprise grasping each of a first body member and a second bodymember. The method may further comprise determining a desired level ofcoupling strength and coupling the first body member to the second bodymember in a first configuration or in a first setting if a high orhigher level of coupling strength is desired and coupling the first bodymember to the second body member in a second configuration or in asecond setting if a low or lower level of coupling strength is desired.

In some embodiments, the method of coupling the break-away connector mayfurther comprise rotating a collar member around a portion of the firstbody member such that the level of coupling strength continuously orincrementally decreases between the first configuration and the secondconfiguration, or rotating the collar member around a portion of thefirst body member such that the level of coupling strength continuouslyor incrementally increases between the second configuration and thefirst configuration. In certain embodiments, the method may compriseengaging a low profile ridge of the first body member with a highprofile ridge of the second body member to couple the first body memberto the second body member in the first configuration. In certain otherembodiments, the method may comprise engaging a high profile ridge ofthe first body member with a high profile ridge of the second bodymember to couple the first body member to the second body member in thesecond configuration. As can be appreciated, additional methods and/ormethod steps can be derived from FIGS. 1A-6D and the correspondingdisclosure.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

References to approximations are made throughout this specification,such as by use of the term “substantially.” For each such reference, itis to be understood that, in some embodiments, the value, feature, orcharacteristic may be specified without approximation. For example,where qualifiers such as “about” and “substantially” are used, theseterms include within their scope the qualified words in the absence oftheir qualifiers. For example, where the term “substantially aligned” isrecited with respect to a feature, it is understood that in furtherembodiments, the feature can have a precisely aligned configuration.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure, orcharacteristic described in connection with that embodiment is includedin at least one embodiment. Thus, the quoted phrases, or variationsthereof, as recited throughout this specification are not necessarilyall referring to the same embodiment.

Similarly, in the above description of embodiments, various features aresometimes grouped together in a single embodiment, figure, ordescription thereof for the purpose of streamlining the disclosure. Thismethod of disclosure, however, is not to be interpreted as reflecting anintention that any claim require more features than those expresslyrecited in that claim. Rather, as the following claims reflect,inventive aspects lie in a combination of fewer than all features of anysingle foregoing disclosed embodiment.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.Moreover, additional embodiments capable of derivation from theindependent and dependent claims that follow are also expresslyincorporated into the present written description.

Without further elaboration, it is believed that one skilled in the artcan use the preceding description to utilize the invention to itsfullest extent. The claims and embodiments disclosed herein are to beconstrued as merely illustrative and exemplary, and not a limitation ofthe scope of the present disclosure in any way. It will be apparent tothose having ordinary skill in the art, with the aid of the presentdisclosure, that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure herein. In other words, variousmodifications and improvements of the embodiments specifically disclosedin the description above are within the scope of the appended claims.Moreover, the order of the steps or actions of the methods disclosedherein may be changed by those skilled in the art without departing fromthe scope of the present disclosure. In other words, unless a specificorder of steps or actions is required for proper operation of theembodiment, the order or use of specific steps or actions may bemodified. The scope of the invention is therefore defined by thefollowing claims and their equivalents.

1. A break-away connector, comprising: a first body member having acoupling end portion and a break-away end portion; and a second bodymember having a coupling end portion and a break-away end portion,wherein the break-away end portion of first body member is configured toengage the break-away end portion of the second body member uponcoupling of the first body member to the second body member, wherein thefirst body member is coupleable to the second body member in one of atleast two configurations, and wherein a greater force is required touncouple the first body member from the second body member when thebreak-away connector is in a first configuration in comparison to whenthe break-away connector is in a second configuration.
 2. The break-awayconnector of claim 1, wherein the break-away end portion of the firstbody member comprises one or more resilient arms, each resilient armhaving one or more ridge portions, wherein the break-away end portion ofthe second body member comprises one or more ridge portions, and whereinthe one or more ridge portions of the first body member are configuredto engage the one or more ridge portions of the second body member uponthe coupling of the first body member to the second body member.
 3. Thebreak-away connector of claim 1, further comprising: a valve disposedwithin at least one of a lumen of the first body member or a lumen ofthe second body member.
 4. The break-away connector of claim 3, whereinthe valve is configured to open when the first body member is coupled tothe second body member.
 5. The break-away connector of claim 3, furthercomprising a valve engagement member disposed within at least one of thelumen of the first body member and the lumen of the second body member,wherein the valve engagement member is configured to open the valve whenthe first body member is coupled to the second body member.
 6. Thebreak-away connector of claim 1, further comprising: a first valvedisposed within a lumen of the first body member; and a second valvedisposed within a lumen of the second body member.
 7. The break-awayconnector of claim 2, wherein the first body member comprises a slot;and wherein the second body member comprises a rib, wherein a portion ofthe rib is configured to be disposed within a portion of the slot whenthe first body member is coupled to the second body member, such thatrotation of the first body member in relation to the second body memberaround a longitudinal axis of the break-away connector is limited. 8.The break-away connector of claim 2, wherein the first body membercomprises two or more resilient arms and a slot is disposed between twoof the resilient arms; and wherein the second body member comprises arib, wherein a portion of the rib is configured to be disposed within aportion of the slot when the first body member is coupled to the secondbody member, such that rotation of the first body member in relation tothe second body member around a longitudinal axis of the break-awayconnector is limited.
 9. The break-away connector of claim 2, whereinthe first body member comprises a first resilient arm and a secondresilient arm, wherein the height of the ridge portion of the firstresilient arm is greater than the height of the ridge portion of thesecond resilient arm; and wherein the second body member comprises afirst ridge portion and a second ridge portion, wherein the height ofthe first ridge portion is greater than the height of the second ridgeportion.
 10. The break-away connector of claim 2, further comprising acollar member disposed around the first body member, the collarlongitudinally displaceable with respect to the first body member, andwherein a portion of the collar member is configured to limit radialmovement of the one or more resilient arms radially outward relative toa longitudinal axis of the break-away connector.
 11. The break-awayconnector of claim 10, wherein displacement of the collar member betweenthe first position and the second position is configured toincrementally decrease a level of coupling strength between the firstbody member and the second body member.
 12. A break-away connector,comprising: a first body member configured to be coupled to a secondbody member such that fluid communication is provided between the firstbody member and the second body member, wherein the first body member iscoupleable to the second body member in at least two configurations, andwherein a greater force is required to uncouple the first body memberfrom the second body member when the break-away connector is in a firstconfiguration in comparison to when the break-away connector is in asecond configuration.
 13. The break-away connector of claim 12, whereinthe first body member is further configured such that fluidcommunication through the first body member is substantially limitedwhen the first body member is uncoupled from the second body member, andwherein the second body member is further configured such that fluidcommunication through the second body member is permitted when the firstbody member is uncoupled from the second body member.
 14. The break-awayconnector of claim 12, wherein the second body member is furtherconfigured such that fluid communication through the second body memberis substantially limited when the second body member is uncoupled fromthe first body member, and wherein the first body member is furtherconfigured such that fluid communication through the first body memberis permitted when the first body member is uncoupled from the secondbody member.
 15. The break-away connector of claim 12, wherein the firstbody member is configured to be coupled to a first medical device, andwherein the second body member is configured to be coupled to a secondmedical device.
 16. The break-away connector of claim 15, wherein thefirst body member is configured to couple the first medical device via acoupling mechanism selected from at least one of a female connector, amale connector, a compression fitting, or a snap fitting; and whereinthe second body member is configured to couple the second medical devicevia a coupling mechanism selected from at least one of a femaleconnector, a male connector, a compression fitting, or a snap fitting.17. The break-away connector of claim 16, wherein the coupling mechanismof the first body member is different from the coupling mechanism of thesecond body member.
 18. A method of coupling a break-away connector,comprising: obtaining each of a first body member and a second bodymember; determining a desired level of coupling strength; and couplingthe first body member to the second body member in a first configurationif a high level of coupling strength is desired and coupling the firstbody member to the second body member in a second configuration if a lowlevel of coupling strength is desired.
 19. The method of claim 18,further comprising rotating a collar member around a portion of thefirst body member such that the level of coupling strength incrementallydecreases between the first configuration and the second configuration.20. The method of claim 18, further comprising engaging a low profileridge of the first body member with a high profile ridge of the secondbody member to couple the first body member to the second body member inthe second configuration.
 21. The method of claim 18, further comprisingengaging a high profile ridge of the first body member with a highprofile ridge of the second body member to couple the first body memberto the second body member in the first configuration.